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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Finnish Regulator Supports Interchangeability of Biosimilars

The Finnish Medicines Agency Fimea has spoken out in support of physician-authorized switching between biosimilars and reference products. Fimea made the recommendation to the Finnish healthcare system after concluding the risks of interchangeability of biosimilars are low.

Officials at Fimea detailed their position on the topic in a four-page document. Fimea concluded switches between biologics, such as when a patient moves from one brand of insulin to another, are common and rarely problematic. Also, evidence of adverse events related to moving from a reference product to a biosimilar is yet to emerge and, in the opinion of Fimea, the theoretical basis for such fears is weak.

Fimea backed up its position by arguing that the risk posed by biosimilars is comparable to that created when a producer of a reference product changes its manufacturing process. The ruling gives Finnish healthcare professionals a mandate to switch between reference products and biosimilars, although the scope of the Fimea’s recommendation does not extend to automatic substitution by pharmacies. Such considerations were outside the scope of the review.

The ruling comes months after the Medicines Evaluation Board (MEB) of the Netherlands reached a similar conclusion. MEB found no meaningful differences in the quality, safety and efficacy of biosimilars and reference products, prompting it to clear doctors to switch between the two.

Swissmedic has missed several of its timeliness targets for the handling of marketing authorization procedures. The Swiss regulator was aiming for an overall on-time rate of 99% and to hit its deadlines in 95% of applications for innovative drugs, but fell short of both objectives.

When data on every procedure handled by Swissmedic in 2014 were collated, the regulator learned it met its deadlines 98% of the time. The figure, while being just below the 99% target, marks a big improvement over the past few years, over which time Swissmedic has met its timeliness goals for around 90% of applications. Improvements in the overall on-time rate were mirrored in the key category of marketing authorizations for innovative medicinal products.

Swissmedic met its timelines in such cases 90% of the time, a slight uptick over 2013 when 88% of applications were processed ahead of their deadline. The regulator was aiming to meet its targets in 95% of cases last year, but its actual rate of 90% still represents a big improvement over historic norms. In 2011, Swissmedic processed 64% of innovative applications on time. Non-innovative products have followed a similar pattern of year-on-year gains, followed by a below-target 2014.

England Rejects 75% of Appeals Against Culling of Products from Cancer Drugs Fund

NHS England has rejected appeals by Eisai, Eli Lilly and Roche against its decision to drop their products from the Cancer Drugs Fund. Bayer was the only company to successfully appeal the original ruling.

The upholding of the original decision means cash will no longer be available for Eisai’s Halaven, Lilly’s Alimta and Roche’s Avastin, although patients already taking the drugs can continue to do so, PMLiVE reports. NHS England cut the drugs from the CDF as part of a reprioritization intended to curb the soaring costs of the program while making new products available. Some of the firms affected are unimpressed by the reasoning, though.

“The CDF Panel upheld a decision made based on a flawed process at a very real cost to the many people who could have benefited from this treatment. They have gone against the views of hundreds of members of the clinical community. The CDF is failing cancer patients at the end of their lives,” Phil Knott, UK director for Lilly oncology, said. Bayer’s stomach cancer therapy Stivarga was the one product to be reinstated to the CDF following an appeal.

The United Kingdom’s Prescription Medicines Code of Practice Authority (PMCPA) has ruled the actions of Otsuka employees in a hotel bar brought discredit upon the pharma industry. PMCPA investigated the case after a complaint that a male Otsuka employee plied an intoxicated woman with drinks.

Some details of the case are disputed, but the basic narrative is that a group of Otsuka staffers bought drinks for an intoxicated meeting attendee. The event took place at a hotel bar after a gala dinner. Having interviewed its staffers, Otsuka accepted the complainant’s version of events is broadly accurate but argued it falls short of being a code violation, in part because it thinks the drunken woman was neither a healthcare professional nor another relevant decision maker.

A PMCPA panel dismissed this defense, ruled Otsuka had brought discredit on the industry and questioned “whether a shared late night social environment could ever be appropriate.” The panel was more lenient on AstraZeneca. In the separate case, the panel ruled a company post on Twitter about breast cancer statistics was not in violation of the code because AstraZeneca had data to substantiate its claim.

EMA Warns of Shortage of Pfizer’s Antibiotic Tygacil

EMA has warned of a shortage of Pfizer’s antibiotic Tygacil. The intravenously administered skin infection treatment is in short supply in multiple European countries after quality control concerns brought manufacturing to a halt.

Pfizer expects to resume distribution next month, but for now most countries in which Tygacil is sold are experiencing shortages. The shortage of the product, global sales of which were $323 million last year, is a consequence of the discovery in March of particles in the vial stoppers. Only certain batches were affected and EMA thinks the particles are unlikely to affect product quality, but Pfizer has nonetheless stopped manufacturing while it takes corrective and preventative steps.

Once Pfizer has completed the remedial work it will restart shipping, with countries experiencing shortages first in line to receive the new batches. In the meantime, EMA is advising doctors to offer alternative treatments to patients.

Lupin has responded to media reports that it risks losing approvals in the GVK Biosciences scandal by detailing its interactions with the European Medicines Agency (EMA) over the past six months. The Indian drugmaker has already redone bioequivalence studies for its two affected products and submitted the data to EMA.

Officials at the Bombay Stock Exchange contacted Lupin for clarification of its regulatory situation after the Financial Express ran an article titled “Some drugs made by Lupin, DRL & Mylan lose EU approval.” While the threat of suspension is hanging over two products from Lupin and 700 drugs from other manufacturers, the Indian company has reason to think it can avoid the punishment. EMA gave companies 12 months to submit new data and avoid suspensions.

Lupin contacted EMA after the original suspension ruling in January and committed to redoing the tests by June. This month the Indian drugmaker submitted data from bioequivalence studies of its two drugs at risk of suspension, trimetazidine MR 35mg and cefpodoxime 200mg. If EMA deems the data sufficient to quash its concerns with the GVK-run bioequivalence tests, it will allow Lupin to continue selling the products in Europe.